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ISO 9001
Executive Overview
What it is, and how to achieve it.

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The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

Executive Overview
► Who is ISO?
► What is a QMS?
► What are ISO 9000 and 9001?
► What are the Benefits of ISO 9001?
► What Does ISO 9001 Require You to Do?
► How Do We Implement ISO 9001?
► What are the Costs of Registration?
► How Long Does it Take to Implement?
► How do we begin?

In the following slides, the ISO 9001:2015 Standard is paraphrased for instructional purposes.
Please Refer to the standard for the actual text.

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The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

Who is ISO?
♦ The International Organization for Standardization
gathers industry professionals from 158 member
countries to develop and improve standards.

♦ ISO authorizes organizations in each member country to

manage the process of accrediting Registrars (ANAB,
etc.)
♦ Registrars audit individual organizations and
recommend them for certification.

♦ It is a 3 year certification
► Year 1 – Registration Audit
► Years 2 & 3 – Surveillance Audits
► (in addition to your internal audits performed constantly)

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The 9000 Store
The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

What is a QMS?
(Quality Management System)

♦ A quality management system (QMS) is a set of policies,

processes and procedures required for planning and execution in
the core business area of an organization. (Good business
practices)
► Core Areas - Areas that can impact the organization's ability to meet
customer requirements:
– Quotations, Purchasing, Production, Shipping, etc.,
– Quality: Must correct errors to achieve consistent results.
♦ ISO 9001:2015 is an example of a Quality Management System.

♦ Read more about a QMS and watch the Demo »

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The 9000 Store
The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

What is ISO 9000?

♦ ISO 9000 is a family of standards for a Quality Management System.
♦ Read about ISO 9000 Family.
► ISO 9000:2015 – Guidance: Fundamentals & Vocabulary for
► ISO 9000 ISO 9001:2015 – The Requirements of the ISO 9000
► Standard
ISO 9004:2009 – Guidance: Managing for sustained
♦ ISO 9001 is an internationally recognized QMS standard which acts
as a quality benchmark when evaluating organizations.

♦ ISO 9001 Registration means you have a QMS in place to control

your processes and deliver consistent results designed to meet the
customer’s requirements.

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The 9000 Store
The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

What is ISO 9001?

ISO 9001:
► Objective: customer satisfaction
► Is industry generic (anyone can use)
► Can be used by both manufacturing and service industries.
► Only tells you WHAT to do, not HOW to do it
► Is NOT a product standard – it contains no product
requirements.

See free tutorial “Basics of ISO 9001” to learn more.

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The 9000 Store
The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

ISO 9001 is Based Upon Several Principles

You should understand these key items
(click each of the following to learn more):

► The Process Approach (Good process>Good results)

► The PDCA model (Plan-Do-Check-Act)

► Risk Based Thinking (Preventive Action)

► Fundamentals of Auditing (Process Based Audit)

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The 9000 Store
The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

Benefits of ISO 9001

External Benefits Internal Benefits

♦ Improved consistency of service ♦ Improved productivity
and product performance and efficiency
♦ Higher customer satisfaction ♦
Cost reductions based upon
♦ levels Improved customer reduced errors
♦ perception ♦
Improved communications,
Competitive advantages and morale and job satisfaction
increased marketing and
sales opportunities. Read about ISO 9001 Benefits and
download a free PowerPoint
► If you meet ISO 9001, a potential customer “Benefits of ISO 9001”
will know you have a solid QMS in place
and likely have good quality.
► This could be a DECIDING FACTOR
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The 9000 Store
The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

Requirements of ISO 9001

(click each of the following to learn more):

ISO 9001 has many requirements which can be summarized as:

♦ Determine the customer requirements.

♦ Establish Quality Policy & Objectives and a work environment necessary to

meet these requirements.

♦ Design and manage a system of inter-related processes to attain objectives.

(QMS)

♦ Measure and analyze the effectiveness of each process in meeting goals and
customer requirements. (Audits)

♦ Continually improve the Quality Management

System

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The 9000 Store
The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

Requirements of ISO 9001

♦ There are 10 sections in the ISO
9001:2015 Standard, summarized
here:
– Scope
– Normative References
– Terms and Definitions
– Context of the Organizatiion
–
Leadership
– Planning
– Support
– Operation
–

– Performan
ce
Evaluation
Sections 4,5,6,7 & 8 contain the requirements and you will
need to address each of them. Specifically…(next page)
Improvement
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The 9000 Store
The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

Major Requirement Clauses of ISO 9001

(click each of the following to learn
more):
♦ Management Responsibility
► Commitment, Customer focus, Policy, Planning, Responsibility,
Authority & Communication, Review

♦ Resource Management
► Human Resources, Infrastructure, Work
Environment
♦ Product Realization
► Customer Requirements, Design, Purchasing,
Operations, Calibration

♦ Measurement and Analysis

► Customer Satisfaction, Audit, Process/Product Control,
Non- conforming product, Data Analysis, Improvement

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The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

Required QMS Documentation

♦ Quality Policy
► Your Organization’s Commitment to Quality
♦ Quality Objectives
► Measurable Quality Goals
which support the Policy
♦ Quality Manual
► What you do to meet the standard
♦ Procedures & Work Instructions
► Outlines steps referenced
in the Quality Manual
♦ Quality Records
► Records & Tables as evidence of QMS performance

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The 9000 Store
The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

Steps to ISO 9001 Certification

(click each of the following to learn more):

Your implementation plan should cover these items:

Learn and understand ISO 9001

– Review ISO 9001 Standard and supporting materials
Perform a Gap Analysis
– Evaluate your current quality system vs. ISO 9001
Plan your project and allocate resources
– People, Money, Time, etc.
Train your organization
– Management Rep, Project Team, Employees, etc.
Create & Document a QMS
– Adding/revising processes
Use and Improve your QMS
– Run your normal organizational activities following the
QMS
Audit your QMS to ensure you meet objectives
– Corrective and Preventive Action when addressing errors
Registration Audit of your QMS (3 year Certification)
– Year 1 = Registration Audit
– Year 2 & 3 Surveillance Audits
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The 9000 Store
The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

ISO 9001 Project Timeline

♦ Varies with Size & Complexity of

Org.
► Many clients are between 3-6 months
► Depends on time and resources applied

♦ Create QMS
► From a few days to several months

♦ Use/Improve QMS & Internal Audit

► Usually 2+ months due to business cycle

The 9000 Store provides several free ISO 9001 project timelines.
♦ Registration Audit - 2
days
► Follow up to fix non-conformances

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The 9000 Store
The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

Costs of Registration
(Costs vary depending on size and complexity of organization)

♦ Creating QMS
► Use templates to save time
► Consultant: $5,000-$50,000
♦ Internal Auditing (No certification is required)
► Train Internal Team of Auditors In House $500
► Send to Internal Auditing Course ~$1200/person
► Hire 3rd Party ~$1000/day ± $400
♦ Costs of Registration Audit (Click to contact a Registrar for a Quote)
► Allowable audit times follow ISO 17021, but vary with Organization
► ~$1400/day ± $200, PLUS travel expenses
► Registration Audit: 2+ days
► Surveillance Audit: 1+ days
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 (877) 942-6572
The 9000 Store
The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

Where Do You Begin?

(click each of the following to learn more):

♦ Follow the 9000 Store Project Manager’s Guide

► Step by Step Guide to ISO 9001 Certification (included in your Quick Start
Kit)
◆ Buy ISO 9001 Certification Package, which includes:
► Gap Checklist Toolkit
► Complete QMS Documentation with Quality Manual, Procedures and Form
Templates for all 20 requirements
► 2.5 Hour Project Team Training
► Employee Training for the Whole Com
► pany Internal Audit Training & Checklist

♦ The 9000 Store provides Free Support for the length of your project
► Call 877-942-6572
► Email questions for your entire project
► Online Resources

♦ Registration - We’ll help you find a Registrar

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 (877) 942-6572
The 9000 Store
The tools you need to achieve and maintain ISO 9001 View All Standards Certifications

Simplify Your Certification Project

♦ Consult the ISO 9001:2015 Project Manager’s Guide

for detailed step by step instructions (Included in the Quick Start Kit)
♦ The 9000 Store has helped thousands of organizations in
more than 40 countries reach certification since 2001.
♦ We’re the original source for ISO 9001 solutions
♦ Our customers have a 100% success rate when it
comes to registrar audits?

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